CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 119 enrolled
Drug / intervention
satralizumab +3 moredrug
Likely dose
satralizumab 120 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04660539
NCT04660539Phase 3Completed
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A Multicenter, Single Arm, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Satralizumab in Patients With Neuromyelitis Optica Spectrum Disorder (NMOSD)

Hoffmann-La Roche·interventional·Posted Dec 9, 2020·Updated Dec 27, 2024

In Brief

A Phase 3 clinical trial evaluating satralizumab, azathioprine (AZA), and 2 other interventions for Neuromyelitis Optica Spectrum Disorder. Completed, enrolled 119 participants across 53 sites in 18 countries.

Detailed Summary

This multicenter, single-arm, open-label study will evaluate the long-term safety and efficacy of satralizumab in participants with neuromyelitis optica spectrum disorder (NMOSD) who completed open-label extension (OLE) period of studies BN40898 and BN40900. Participants will receive satralizumab as monotherapy or in combination with one of the following background immunosuppressive treatments: azathioprine (AZA), mycophenolate mofetil (MMF), or oral corticosteroids.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeuromyelitis Optica Spectrum Disorder
CountriesBulgaria, Canada, Croatia, Germany, Hungary, Italy, Japan, Malaysia, Poland, Puerto Rico, Romania, South Korea, Spain, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedDec 9, 2020
Enrollment StartMar 2, 2021
Primary CompletionMay 28, 2024
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 5.6 years ago

Interventions

satralizumabdrug

Satralizumab will be administered by SC injection in the abdominal or femoral region at a dose of 120 mg (fixed dose) Q4W for up to 3 years

azathioprine (AZA)drug

Participants are permitted to use AZA during the study as background immunosuppressive treatment at a maximum dose of 3 milligram per kilogram per day (mg/kg/day)

mycophenolate mofetil (MMF)drug

Participants are permitted to use MMF during the study as background immunosuppressive treatment at a maximum dose of 3000 mg/day

oral corticosteroidsdrug

Participants are permitted to use oral corticosteroids (prednisolone equivalent) during the study as background immunosuppressive treatment at a maximum dose of 15 mg/day